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Centers for Medicare & Medicaid Services

National Coverage Analysis (NCA) Tracking Sheet for Positron Emission Tomography (FDG) for Solid Tumors (CAG-00181R)

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Positron emission tomography (PET) is a non-invasive imaging procedure used to assess metabolic activity and perfusion in various organs or tissues in the human body. Images are obtained by processing of emissions from positron-emitting radioisotopes that are usually administered intravenously. 2-[F18] fluoro-2-deoxy-D-glucose (FDG) is the radioisotope commonly used in oncologic FDG PET imaging procedures.

The rate of FDG decay provides information on glucose metabolism of tissues being studied. As malignancies can cause abnormalities of glucose metabolism, FDG PET evaluation can indicate the probable presence or absence of malignancy based upon observed differences in biologic activity of adjacent tissues.

Section 220.6 of the National Coverage Determination (NCD) Manual establishes the requirement for prospective data collection for FDG PET used in the diagnosis, staging, restaging and monitoring response to treatment for brain, cervical, ovarian, pancreatic, small cell lung and testicular cancers, as well as for cancer indications not previously specified in Section 220.6 in its entirety.

The requestors have asked CMS to reconsider Section 220.6 to end the data collection requirements across all oncologic indications except for monitoring response to treatment.

We have received public input indicating that the current coverage framework which required cancer by cancer consideration of diagnosis, staging, restaging and monitoring response to treatment should be replaced by a more omnibus consideration. Though that coverage framework has been useful, we are open to public input that it be retired and that a general policy could be developed and applied to oncologic FDG PET imaging.

The following sections of the National Coverage Determination Manual currently address solid tumors:
220.6.2 - Lung cancer
220.6.3 - Esophageal cancer
220.6.4 - Colorectal cancer
220.6.5 - Lymphoma
220.6.6 - Melanoma
220.6.7 - Head and neck cancers
220.6.10 - Breast cancer
220.6.11 - Thyroid cancer
220.6.12 - Soft tissue sarcoma
220.6.14 - Brain, cervical, ovarian, pancreatic, small cell lung and testicular cancers
220.6.15 - All other cancer indications not previously specified

We have broadened the scope of this review through an announcement on our website and are soliciting additional public comment on the use of FDG PET imaging for other solid tumors. We are also soliciting public suggestions for possible alternatives to the current coverage framework described above.
Diagnostic Tests (other)
Requestor Name(s):  See Actions Taken
Requestor Letter(s):  View Letter
Formal Request Accepted and Review Initiated:  04/10/2008
Expected NCA Completion Date:  04/06/2009
Public Comment Period:  09/16/2008 - 10/17/2008
Proposed Decision Memo Due Date:  01/10/2009
Proposed Decision Memo Public Comment Period: 01/06/2009 - 02/05/2009 
Decision Memo Released:  04/03/2009
Comments for this NCA::  View Public Comments
Lead Analyst(s): 
Lead Medical Officer(s): 
  • Jeffrey Roche, MD, MPH
April 10, 2008

Requestors:

Bruce E. Hillner, MD
Professor and Associate Chair of Information Sciences Department of Internal Medicine
Virginia Commonwealth University

R. Edward Coleman, MD
Professor of Radiology
Vice-Chairman, Department of Radiology
Director, Division of Nuclear Medicine
Duke University School of Medicine

Anthony F. Shields, MD, PhD
Professor of Medicine and Oncology
Karmanos Cancer Institute

Barry A. Siegel, MD
Chief, Division of Nuclear Medicine Mallinckrodt Institute of Radiology
Professor, Department of Radiology
Washington University School of Medicine

CMS opens this reconsideration of the NCD on Positron Emission Tomography (PET). The formal request is to remove the current prospective data collection requirements as required for certain cancers in Section 220.6 of the National Coverage Determination Manual. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the technology under review.

Instructions on submitting comments can be found at: http://www.cms.hhs.gov/InfoExchange/02_publiccomments.asp#TopOfPage

To submit a comment, please use the orange "Comment" button at the top of the page.
June 10, 2008

CMS will convene the Medicare Evidence Development and Coverage Advisory Committee on August 20, 2008. The panel will review the scientific evidence of the impact of PET as part of a cancer management strategy to improve patient-centered outcomes. The panel will also consider data generated pursuant to prior national coverage determination to cover PET for specified cancers when additional data are prospectively collected.

Due dates amended.
September 16, 2008

We have received public input indicating that the current coverage framework which required cancer by cancer consideration of diagnosis, staging, restaging and monitoring response to treatment should be replaced by a more omnibus consideration. Though that coverage framework has been useful, we are open to public input that it be retired and that a general policy could be developed and applied to oncologic FDG PET imaging.

The following sections of the National Coverage Determination Manual currently address solid tumors:
220.6.2 - Lung cancer
220.6.3 - Esophageal cancer
220.6.4 - Colorectal cancer
220.6.5 - Lymphoma
220.6.6 - Melanoma
220.6.7 - Head and neck cancers
220.6.10 - Breast cancer
220.6.11 - Thyroid cancer
220.6.12 - Soft tissue sarcoma
220.6.14 - Brain, cervical, ovarian, pancreatic, small cell lung and testicular cancers
220.6.15 - All other cancer indications not previously specified

We have broadened the scope of this review through an announcement on our website and are soliciting additional public comment on the use of FDG PET imaging for other solid tumors. We are also soliciting public suggestions for possible alternatives to the current coverage framework described above. CMS broadens the scope of this analysis to include the use of FDG PET in solid tumors.

To reflect the expanded scope of this analysis, the tracking sheet is renamed as follows: NCA Tracking Sheet for Positron Emission Tomography (FDG) for Solid Tumors (CAG-000181R)

A new 30-day public comment period regarding the expanded scope of this NCA begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the technology under review.

Instructions on submitting comments can be found at: http://www.cms.hhs.gov/InfoExchange/02_publiccomments.asp#TopOfPage To submit a comment, please use the orange "Comment" button at the top of the page.
January 6, 2009

CMS posts the proposed decision memorandum and opens a 30 day public comment period on the proposed decision.

Instructions on submitting comments can be found at: http://www.cms.hhs.gov/InfoExchange/02_publiccomments.asp#TopOfPage

To submit a comment, please use the orange "Comment" button at the top of the page.
April 3, 2009 CMS posts the final decision memorandum.
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